Regulatory/GMP Compliance

Oct 02, 2018
Pharmaceutical Technology
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
Oct 02, 2018
Pharmaceutical Technology
Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
Sep 28, 2018
While food, shelter, and clothing are the primal essentials for life, hope—as embodied by modern medicine—has now become part of that human expectation.
Sep 28, 2018
By Pharmaceutical Technology Editors
The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.
Sep 28, 2018
By Pharmaceutical Technology Editors
As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.
Sep 27, 2018
By Pharmaceutical Technology Editors
The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.
Sep 27, 2018
By Pharmaceutical Technology Editors
The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Sep 27, 2018
By Pharmaceutical Technology Editors
The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.
Sep 27, 2018
By Pharmaceutical Technology Editors
The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.
Sep 27, 2018
CDER director plans to start implementation of new review practices by the end of 2018.
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